Oral contraception for females aged 18-45 MedDRA version: 20.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Chemo Research S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Sexually active, postmenarcheal and premenopausal female subjects, at risk of pregnancy, aged between 18-45 years (inclusive) at the time of trial enrolment. 2.Women who a.have never used hormonal contraceptives before consent (naïve users), b.have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) or c.directly switch from another hormonal contraceptive (switchers). 3.Only for subjects who were not pregnant and did not use hormonal contraception during the last six months before consent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months. 4.Only for women who were pregnant within the last six months before consent: At least three complete menstrual cycles after pregnancy. 5.At screening, systolic blood pressure minor or equal 140 mm Hg and diastolic blood pressure minor or equal 90 mm Hg. 6.Be able and willing to provide written informed consent prior to undergoing any trial-related procedure. 7.Willing to use trial contraception for nine 28-day cycles. 8.Be willing to have intercourse in each cycle of the trial without the need to use back-up contraception. 9.Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile. 10.Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1018 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Pregnancy. 2.Wish for pregnancy. 3.Breastfeeding. 4.Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary. 5.History of infertility. 6.Body Mass Index (BMI) 30 kg/m2. 7.Current smokers with age > 35 years (at the time of trial enrolment). 8.Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial. 9.Women 21 years of age or older with a Papanicolaou (Pap) smear reading low grade of squamous intraepithelial lesion (LGSIL) or higher at screening (or six months prior to screening date). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASC-US) can be used as an adjunctive test. Subjects with ASC-US can be included if they are negative for high-risk HPV strains. Subjects < 21 years of age do not require a Pap smear. 10.Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including: a.Presence or risk of a venous thromboembolism (VTE) b.Presence or risk of an arterial thromboembolism (ATE) c.Presence or history of pancreatitis, if it is associated with severe hypertriglyceridemia d.Presence or history of liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome) e.Current or previous liver tumours f.Known or suspected sex hormone-dependent malignant tumours (e.g., breast, genital organs or endometrium) g.Undiagnosed vaginal bleeding h.Unexplained amenorrhoea i.Concomitant use of medicinal products containing ombitasvir / paritaprevir / ritonavir or dasabuvir j.Severe renal insufficiency or acute renal failure. 11.Uncontrolled thyroid disorder (i.e., not on stable dose of thyroid replacement for at least than two months at the time of consent). 12.Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months at the time of consent). 13.Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent). 14.Known HIV infection. 15.Known current or chronic hepatitis B or C. 16.Known HPV infection with strains 16, 18 or other high-risk strains as per screening examination 17.Less than 3 menses after discontinuing dosing of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) or any combined injectable contraceptive (e.g. Cyclofem®) prior to consent. 18.Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.: a.Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate) b.Barbiturates (e.g. primidone) c.Specific antibiotics (such as rifampicin [tuberculosis infection], griseofulvin [fungal infections]) d.HIV medication (such as ritonavir, neviparine and efavirenz) e.Bosentan f.St. Johns wort (hypericum perforatum) g.Metoclopramide 19.Prohibited medication including the use of oestrogens, progestogens, strong microsomal enzyme-inducing drugs (intensive and moderate frequency). 20.Prohibited medications that may increase serum potassium (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin and aldosterone antagonists). 21.Administration of medication containing human chorionic gonadotropin (hCG) within a month pri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the contraceptive efficacy of LPRI-424;Secondary Objective: To demonstrate the safety and tolerability of LPRI 424 in comparison to DRSP 3 mg / EE 0.02 mg, especially regarding bleeding pattern;Primary end point(s): Overall Pearl Index (PI) in women aged equal or minor 35 years (at the time of trial enrolment);Timepoint(s) of evaluation of this end point: After trial termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Overall PI in all women and in women aged > 35 years (at the time of trial enrolment) 2.PI after correction for back-up contraception and sexual activity (evaluable cycles) in all women 3.PI after correction for back-up contraception and sexual activity (evaluable cycles) in women aged equal or minor 35 years and in women aged > 35 years (at the time of trial enrolment) 4.PI for method failures in all women 5.PI for method failures in women aged equal or minor 35 years and in women aged > 35 years (at the time of trial enrolment) 6.Pregnancy ratio by life table analysis in all women 7.Pregnancy ratio by life table analysis in women aged equal or minor 35 years and in women aged > 35 years (at the time of trial enrolment) Safety/Tolerability: 8.AEs 9.Vital signs 10.ECG 11.Clinical laboratory parameters 12.Special clinical laboratory parameters (in a subset of at least 40 subjects per treatment group): •Haemostatic variables •Carbohydrate metabolism •Bone mineral density biomarkers 13.Physical examination 14.Gynaecological examination 15.Transvaginal ultrasound examination 16.Mastodynia/mastalgia and dysmenorrhoea characteristics as well as cervical cytology 17.Vaginal bleeding pattern 18.IMP acceptability 19.Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF);Timepoint(s) of evaluation of this end point: After trial termination | — |
Countries
Czech Republic, Germany, Hungary, Poland, Portugal, Slovakia, Spain, Ukraine
Contacts
Public ContactChief Scientific Officer
Chemo Research S.L.
Outcome results
None listed